Biosimilars: Much Ado About Nothing, Part 2

By Brittany | March 30, 2012 | Category: Pharmacotherapy
Biosimilars: Much Ado About Nothing, Part 2
By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC
Middletown, NJ

Let’s not forget the reason for the FDA’s existence. The agency was formed to assure the purity of food and drug products (1906). They went on to regulate drug safety (1937) and then drug efficacy (1962). The efficacy regulations were in response to what was truly a safety issue—the use of thalidomide in pregnant women. The FDA is the institutionalized embodiment of the Hippocratic Oath to “first do no harm.” They are cautious because that is their job. Safety does come first. You can always replace a drug that’s not working, but you cannot replace a patient who has died. Suggesting biosimilars could be approved without clinical data is not a very cautious position to take and leads one to wonder about the possible motivation of the FDA in taking that position.

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Biosimilars: Much Ado About Nothing, Part 1

By Brittany | March 23, 2012 | Category: Pharmacotherapy
Biosimilars: Much Ado About Nothing, Part 1
By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC
Middletown, NJ

The eagerly awaited draft guidance on biosimilars* was finally issued by the FDA on February 9, 2012. It was drafted in the spirit of enlightened health care reform, with a view towards fiscal responsibility and. . . to annoy the nemesis of all that is good in health care, “Greedy Big Pharma.”

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Substitution of Doxil in Ovarian Cancer? There Must Be a Better Way

By Brittany | February 28, 2012 | Category: Cancer, Ovarian cancer, Pharmacotherapy
Substitution of Doxil in Ovarian Cancer? There Must Be a Better Way
By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC
Middletown, NJ

The FDA’s most recent response to the anti-cancer drug shortage crisis may be a perfect example of “too little, too late.” What follows will not be a rant about offshore outsourcing or the regulatory climate in general. However, the FDA decision (See FDA’s Press Release regarding shortages of anti-cancer drugs here) to allow Sun Pharma’s version of Doxil (doxorubicin HCl liposome injection) into the United States to replace the approved Ben Venue product may be a dangerous one for patients with ovarian cancer.

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